Cymbalta® Withdrawal Lawsuits

Cymbalta Withdrawal Has Severe Consequences and Side Effects

Shortly after Cymbalta was introduced on the market, many people who used Cymbalta reported that they would experience dramatic withdrawal side effects, such as “brain zaps” or electric shock sensations, body zaps, extreme mood swings, agitation, nausea, and dizziness. A Cymbalta withdrawal study by the drug’s manufacturer Eli Lilly and Co (Lilly) confirmed this experience, finding that withdrawing from Cymbalta often produces severe adverse effects that continue for weeks following discontinuation of the drug.

In the study, the Lilly investigators looked at nine previous trials in which patients had been abruptly withdrawn from Cymbalta. Six were short-term (8-9 weeks) studies and three were long-term studies that lasted for at least 30 weeks. In the short term trials, 44.3% of the patients treated with Cymbalta experienced one or more withdrawal effects. In a large trial included in the Cymbalta withdrawal study involving 1,279 patients, 51% experienced withdrawal symptoms.

The most common withdrawal symptoms associated with Cymbalta were:

• Dizziness
• Nausea
• Headache
• Paresthesia (electric shock sensations in the brain or “brain zaps”)
• Diarrhea
• Vomiting
• Irritability
• Insomnia
• Nightmares
• Hyperhidrosis (excessive sweating)

In spite of knowing about these side effects, Lilly overplayed the efficacy of Cymbalta. Seeking to capture a greater segment of the antidepressant market in 2005, Lilly initiated a direct-to-consumer marketing campaign with the tagline: “Depression hurts. Cymbalta can help.” Cymbalta advertisements bearing this slogan appeared ubiquitously on television, in print, and on the internet. Lilly’s advertising campaign made it appear that Cymbalta not only treated depression, but that it also treated physical pain associated with depression.

Scientists who reviewed the Cymbalta data have since concluded that Lilly’s claims were misleading. For example, in a 2008 article published in Psychotherapy and Psychosomatics, the author concluded that “the marketing of duloxetine as an antidepressant with analgesic properties for people with depression does not appear to be adequately supported.”

How Did Lilly Manipulate Doctors and the Media?

Lilly also augmented its misleading advertising campaigns by engaging in selective and biased publication of its clinical trials of Cymbalta. In a 2008 study published in the New England Journal of Medicine, researchers obtained clinical trials for antidepressants (including Cymbalta) that had been submitted to the FDA and compared them with studies that had been published. The authors found that there was a clear “bias towards the publication of positive results” and that, “according to the published literature, it appeared that 94% of the trials conducted were positive. By contrast, the FDA analysis shows that 51% were positive.”

The authors found that, as a result of such selective publication, the published literature conveyed a misleading impression of Cymbalta’s efficacy, resulting in an apparent effect size that was 33% larger than the effect size derived from the full clinical trial data. Because of all these efforts – including the direct-to-consumer promotional campaigns, misleading presentation of Cymbalta’s efficacy, and failure to adequately warn regarding Cymbalta’s withdrawal and dependency side effects – Cymbalta eventually became a “blockbuster” drug with over $3 billion dollars in annual sales, making it the second-most profitable drug in Lilly’s product line.

Industry Watchdog Issues Damaging Findings About Cymbalta Withdrawal

In October 2012, the Institute for Safe Medication Practices (ISMP), a non-profit healthcare consumer safety watchdog, issued findings from its independent investigation of Cymbalta adverse events found in the FDA Adverse Event Reporting System (FAERS). The ISMP’s investigation uncovered “a signal for serious drug withdrawal symptoms associated with duloxetine (Cymbalta),” and detailed for the public what Lilly already knew: “Withdrawal symptoms were reported in 44-50% of patients abruptly discontinuing duloxetine at the end of clinical studies for depression, and more than half of this total did not resolve within a week or two.”

The ISMP report continued: “[W]e identified a serious breakdown at both the FDA and the manufacturer, Eli Lilly and Company, in providing adequate warnings and instructions about how to manage this common adverse effect.” Additionally, the FDA-approved patient guide for Cymbalta was found to be “materially deficient,” giving no hint of the persistence or severity of symptoms.

It does not address basic questions about withdrawal like:

• What kind of symptoms are most common?
• Should patients taper off the dose, and if so, how slowly?
• What should a patient do if depression or other symptoms recur?
• Is there a way to tell whether these are withdrawal symptoms or the previous illness returning?

Holding Lilly Accountable for Dangerous Drug Defects

Declassified court documents obtained by Baum Hedlund during the course of our Cymbalta withdrawal litigation confirmed that Lilly was well aware of Cymbalta’s withdrawal risks, that they occur frequently, and can be quite severe. Instead of being upfront about the risk, however, Lilly hid behind a misleading label, making it appear that the risk was rare and symptoms mild.

Over the past 40 years, our Los Angeles litigation team at Baum Hedlund has led the way in fighting back against these kinds of practices at drug manufacturing companies like Lilly, taking on many cases related to Cymbalta withdrawal, antidepressant-related birth defects, and other dangerous examples of negligence. Our team also helped bring about the black box suicidality warning for children and young adults, now on most antidepressant labels, after finding an internal drug company study linking SSRIs to cardio birth defects. We are also consumer advocates who have testified before state and federal governments on numerous occasions in order to improve consumer and product safety, with many of our attorneys serving in leadership positions on 23 Plaintiffs’ Steering Committees, which oversee complex cases in multi-district litigation.